Condition category
Cancer
Date applied
06/11/2008
Date assigned
11/12/2008
Last edited
09/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Helen Phillips

ORCID ID

Contact details

Wales Cancer Trials Unit
School of Medicine
Cardiff University
6th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 (0)29 2068 7461
helen.phillips@wctu.wales.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01097317

Protocol/serial number

1.0

Study information

Scientific title

Is NeuroMuscular Electrical Stimulation an acceptable and feasible supportive therapy for patients with non-small cell lung cancer receiving palliative chemotherapy?: an open randomised phase II trial

Acronym

NMES

Study hypothesis

Primary: Is NMES an acceptable supportive therapy for patients with non-small cell lung cancer undergoing at least 3 cycles of palliative chemotherapy?
Secondary:
i) Is NMES a safe intervention to offer patients undergoing palliative chemotherapy?
ii) To what extent does 3 cycles of palliative chemotherapy impact on leg muscle strength, body composition and physical activity levels in patients with NSCLC and can the use of NMES influence these changes?
iii) What is the rate of recovery or decline in these parameters following cessation of 3-4 cycles of chemotherapy and can the use of NMES influence this?
iv) What are patients’ attitudes about the use of NMES during chemotherapy?

As of 24/02/2011 the anticipated end date for this trial has been updated from 01/02/2011 to 01/02/2012.

Ethics approval

Nottingham 1 REC on 21/04/2009 (ref: 9/H0403/24)

Study design

Open randomised controlled phase II trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Non-small cell lung cancer

Intervention

Participants will be randomly allocated (1:1 allocation ratio) to receive one of the following treatment regimen(s):

Control arm: Three to four cycles of first line palliative chemotherapy with carboplatin/vinorelbine administered as part of usual care by Nottingham University Hospital NHS Trust staff. Each chemotherapy cycle is planned to last for 21 days and consists of an administration of vinorelbine and carboplatin (day 1 of cycle) and a second administration of vinorelbine one week later (day 8 of cycle).

Intervention arm:
The palliative chemotherapy described above plus NMES.

NMES programme:
NMES for 30 min daily at home to the anterior thighs throughout chemotherapy. Because patients are generally anxious about starting chemotherapy we will defer initiating NMES until one week after commencing cycle one. A physiotherapist will supervise the first session of NMES either at hospital or in the patient's home depending on patient preference. This will be supplemented by written instructions, weekly phone calls and home visits if required. Stimulation will be delivered using a MicroStim Exercise Stimulator MS2v2 (Odstock Medical Ltd, UK) and self-adhesive electrodes placed over the body of the quadriceps. The intensity or amplitude (device output 0-120 mA, tested across 1,000 ohm) will initially be set to elicit a visible and comfortable muscle contraction. Thereafter, patients will be encouraged to increase the amplitude as tolerated during the monitoring phone calls. The proportion of the treatment duration which is active, i.e. the stimulation is on, will increase on a weekly basis from 11% to 18% to 25%, remaining constant thereafter.

Contact details of Principal Investigator:
Dr Andrew Wilcock
Hayward House Macmillan Specialist Palliative Cancer Care Unit
Nottingham University Hospitals NHS Trust
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Email: andrew.wilcock@nottingham.ac.uk

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Adherence to NMES: Proportion of patients completing a pre-determined level of compliance to the recommended NMES programme (NMES for 30 min three times a week) measured using a self-report daily diary.

The primary and secondary outcomes will be assessed at baseline, end of treatment at week 9 or 12 (depending on 3 or 4 chemotherapy cycles), follow-up assessments at week 17 or 20 (depending on 3 or 4 chemotherapy cycles).

Secondary outcome measures

1. Safety of NMES: real-time adverse event reporting using the Common Terminology Criteria for Adverse Events (CTC AE) v3.0
2. Quadriceps muscle strength: peak torque (Nm) measured using a portable Manual Muscle Tester® dynamometer (Lafayette Instruments, USA)
3. Body composition: lean tissue mass of the body and thighs (kg) assessed by low-dose dual energy x-ray absorptiometry (DEXA)
4. Physical activity level: mean daily step count assessed by a small, lightweight activPAL™ accelerometer worn on the thigh for one week
5. Response to chemotherapy: overall objective clinical response categorised using Response Evaluation Criteria In Solid Tumours, documented from patients' medical reports
6. Nutritional intake: mean daily energy (kJ/d) and protein (g/d) intake estimated from a 3-day food and drink diary
7. Fatigue: Multidimensional Fatigue Inventory
8. Quality of life: the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) and the lung cancer specific module EORTC QLQ-LC13

The primary and secondary outcomes will be assessed at baseline, end of treatment at week 9 or 12 (depending on 3 or 4 chemotherapy cycles), follow-up assessments at week 17 or 20 (depending on 3 or 4 chemotherapy cycles).

Overall trial start date

01/02/2009

Overall trial end date

01/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, 16 years or over
2. Informed consent
3. Histological diagnosis of NSCLC
4. Eastern Collaborative Oncology Group (ECOG) Performance Status of 0, 1 or 2
5. Scheduled to receive 3-4 cycles of first line palliative chemotherapy with carboplatin/vinorelbine

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

52

Participant exclusion criteria

1. Implanted cardiac pacemaker
2. Epilepsy
3. Spinal cord pathology
4. Pregnancy

Recruitment start date

01/02/2009

Recruitment end date

01/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wales Cancer Trials Unit
Cardiff
CF14 4YS
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Research and Commercial Division (RACD)
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom
+44 (0)29 2087 5834
shawc3@cardiff.ac.uk

Sponsor type

University/education

Website

http://www.cardiff.ac.uk

Funders

Funder type

Other

Funder name

National Cancer Research Institute (NCRI) Supportive and Palliative Care (SuPaC) Research Collaboration (UK) (ref: LCSuPaC 35)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24386491

Publication citations

  1. Results

    Maddocks M, Halliday V, Chauhan A, Taylor V, Nelson A, Sampson C, Byrne A, Griffiths G, Wilcock A, Neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer receiving palliative chemotherapy: a randomized phase II study., PLoS ONE, 2013, 8, 12, e86059, doi: 10.1371/journal.pone.0086059.

Additional files

Editorial Notes